Fairtility, a global leader in transparent AI for reproductive care, today announced that its CHLOE platform has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for one of its AI-powered embryo assessment tools, CHLOE Blast™, making it the first and only FDA-cleared machine learning AI-powered clinical decision support software for embryo assessment.

The embryo assessment function of CHLOE analyzes time-lapse embryo images to enable more objective and consistent evaluations. Backed by robust clinical evidence, the CHLOE suite is designed to enhance the standard of care by improving workflow efficiency and bringing transparency to the IVF patient’s journey.

“With this first FDA clearance, CHLOE is setting a regulatory precedent in this space,” said Eran Eshed, CEO & Co-Founder of Fairtility. “We are shifting the industry from subjective and manual assessment to an objective, data-driven and more automated one. This clearance allows us to offer clinics and patients in the U.S. the same AI-powered technology that has been successfully implemented in many countries across Europe, Canada and Asia Pacific.”

Commercially used with tens of thousands of patients outside of the U.S., CHLOE supports embryologists with consistent embryo and oocyte assessments, helps doctors communicate more clearly with patients, provides management with data-driven visibility, and empowers patients with greater transparency and engagement.

“This FDA clearance marks a turning point where years of AI research translate into real progress for patients,” said leading U.S.-based assisted reproductive Lab Director, Jason Barritt, PhD, HCLD. “With CHLOE, IVF decision-making becomes more consistent, transparent, and empowering for both clinicians and patients, setting the stage for the future of individualized reproductive care and improved outcomes.”

AI-powered tools that can improve the precision and consistency of embryo selection represent a crucial advancement in helping more couples achieve successful pregnancies. According to the CDC’s latest National Health Statistics Report, infertility rates among married women in the United States have risen, increasing from 6.7% in 2011–2015 to 8.7% in 2015–2019. With nearly 1 in 10 married women of reproductive age now facing infertility challenges.

“This technology represents a meaningful advancement in the practice of fertility care. Through continuous monitoring of embryo development with time-lapse imaging, coupled with explainable artificial intelligence, it provides physicians with real-time, interpretable insights without adding unnecessary complexity to the workflow,” said Dr. Said Daneshmand, Reproductive Endocrinologist with San Diego Fertility Center. “By integrating seamlessly with the embryology laboratory, it strengthens confidence in critical decision-making and fosters closer collaboration between clinicians and embryologists. Just as importantly, it expands the number of measurable datapoints available to physicians, offering a more objective foundation for guiding patients through their treatment. In doing so, it has the potential to redefine how data and clinical judgment come together to improve outcomes in reproductive medicine.”

“This FDA clearance is more than a regulatory milestone,” said Moti Shniberg, Founder of Nacre Capital, an investor in Fairtility. “It reflects Fairtility’s leadership in bringing AI into reproductive medicine and marks the beginning of a new era of standardization, transparency, and improved outcomes for patients and clinics alike.”

About Fairtility

Fairtility is a global leader in transparent AI solutions for reproductive medicine. Its comprehensive CHLOE platform leverages time-lapse imaging and AI to enhance decision-making across the IVF journey, from embryo and oocyte assessment to workflow optimization. Backed by robust clinical evidence and adopted by fertility clinics worldwide, Fairtility is committed to advancing the standard of care, improving patient outcomes, and fostering greater transparency in reproductive treatment. For more information, visit www.fairtility.com.

About Nacre Capital

Nacre Capital is a global venture builder focused on building impactful AI based deep-tech companies. The Nacre portfolio includes FDNA, the leader in AI based solutions to solve rare diseases and Seed-X, transforming crop production using AI, among others.

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